The Study of Heart Failure With Human Umbilical Cord Mesenchymal Stem Cells (hUC-MSC)
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Heart color ultrasound evaluation
研究概览
简要总结
The purposes of the study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cells (hUC-MSC) in treating heart failure patients
详细描述
This is a randomized, paralleled study. Patients will be divided into two groups of treatment and control. all of them will receive conventional treatment based on specific condition, including digitalis, milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), and antiplatelet aggregation etc. Treatment group patients will receive hUC-MSC. Follow-up visit will occur on 3 months, 6 months, and 12 months after the cell transfusion. Vital signs, blood routine test, urine routine test, liver function examination, etc, will be placed to evaluate the safety of hUC-MSC treatment. And the change of symptoms to evaluate the efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •volunteer to participate in clinical trial, and sign informed consent form
- •with cardiac failure symptoms, including oppression in chest, breathe hard, lower limb edema. And new york heart association class as two to four
- •heart color ultrasound indicate left ventricular ejection fraction (LVEF) < 40%
- •content of serum NT-proBNP > 450pg/ml
排除标准
- •with severe drug allergy history or allergic constitution
- •patients were severe infected
- •with malignant tumor or with high tumor marker
- •with severe cardiorespiratory dysfunction, hematological system disease
- •with severe mental disorder, cognitive impairment
- •with persistent atrial fibrillation, valvular heart disease, dilated cardiomyopathy, hypertrophic cardiomyopathy or restrictive cardiomyopathy patients
- •end-stage renal insufficiency, pregnancy, or breast feeding women
- •bleeding tendency, active gastrointestinal ulcer
- •recent have major surgery, stroke, cancer, hepatic function insufficiency or other life-threatening condition.
- •under other therapy that possibly influence MSC security or efficacy
- •donor: HIV, active hepatitis B/C infection, Syphilitic antibody positive
- •participant/donor: alcoholism, drug addicted, mental disease
研究组 & 干预措施
Treatment group
conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.
干预措施: Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) (Biological)
Treatment group
conventional treatment; Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) by i.v.
干预措施: conventional treatment (Drug)
Control group
Conventional treatment
干预措施: conventional treatment (Drug)
结局指标
主要结局
Heart color ultrasound evaluation
时间窗: 12 months
Criteria: * Excellent: ejection fraction improve to \> 50%; * Efficient: ejection fraction improved; * Inefficient: ejection fraction same as before treatment; * Exacerbation: ejection fraction declined.
次要结局
- Single therapy effectiveness evaluation(12 months)